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en-usTechdirt. Stories filed under "pharmaceuticals"https://ii.techdirt.com/s/t/i/td-88x31.gifhttps://www.techdirt.com/Tue, 21 Nov 2017 09:31:42 PSTNobel Prize Winning Economist Says Non-US Countries Have Unique Opportunity To Reform Intellectual PropertyMike Masnickhttps://www.techdirt.com/articles/20171119/23322238646/nobel-prize-winning-economist-says-non-us-countries-have-unique-opportunity-to-reform-intellectual-property.shtml
https://www.techdirt.com/articles/20171119/23322238646/nobel-prize-winning-economist-says-non-us-countries-have-unique-opportunity-to-reform-intellectual-property.shtml
For well over a decade, we've noted that Nobel Prize-winning economist Joe Stiglitz has been one of the many, many economists who are skeptical of the benefits of our current patent system, noting that it appears to do a lot more harm than good, both to the process of innovation and (importantly) to the wider distribution of the gains from innovation. He's been particularly critical of pharmaceutical patents over the years. And, it appears that he may sense a somewhat unique opportunity to actually get countries around the world to actually rethink traditional patent and copyright regimes -- in part because the US, under the Trump administration, is pulling back from various international agreements and fora.

Earlier this year, along with Dean Baker and Arjun Jayadev, Stigliz authored an interesting paper about ways to rethink innovation, intellectual property and development. I don't necessarily agree with everything in the paper, but I do agree with much of it -- especially the presentation of the problems of today's systems.

Today’s global intellectual property regimes have been
strongly affected by the historical evolution of IPR in the United States and in the
advanced industrialised countries over the last century. Certainly, the adoption
of the World Trade Organization’s Trade Related Intellectual Property System
(TRIPS) reflects the understanding of the management of intellectual and
knowledge advancement that prevailed in the last quarter of the previous century
and the structure of economic power at that moment.

Perhaps somewhat ironically the world has coalesced on a set of institutions to
manage knowledge advancement just as advanced industrialised economies
have begun to run up against the severe impediments that this system entails - a
system that they thought had been designed by and for themselves. Nowadays,
it is widely recognised that the management of innovation in countries like the
US has been sub-optimal and led to a situation that is increasingly litigious
and plagued by conflicts. In fields such as information technology, a whole
set of weak patents and an epidemic of over-patenting has made subsequent
innovation difficult and has eroded some of the gains from knowledge creation
(see Bessen and Meurer, 2008 among others). Moreover, in some areas, such
as in pharmaceuticals, ever-stronger IP protections has not necessarily led
to an increase in the discovery of new chemical entities (see Dosi and Stiglitz,
2014). Rather, the demands and needs of different industries become more
opposed, leading to serious concerns for policy makers. There is a shrinking of
the knowledge commons as even publicly funded and promoted innovation is
privatised, thereby reducing both equity and efficiency. There is no agreement
on what exactly ought to be done, but it is certainly recognised that the current
system is not satisfactory for developed countries.

As you can tell from that snippet from the intro, there's a lot of concern about how US-driven "harmonization" of (mainly) patent rights has done more harm than good -- especially in believing in a one-size-fits-all approach. However, the paper notes that it's difficult to move away from the older setup, since so many countries were pressured into joining TRIPS (and some other international trade agreements).

The whole paper is worth reading (and it's embedded below, based on the Creative Commons license on the paper -- though, oddly, they never designate which CC license is actually being used, but I believe our posting here would be covered by all CC licenses). But beyond the paper, it appears that Stiglitz is sensing an unfortunate, if unique, opportunity to actually make other countries consider moving away from the old patent regimes: The administration of Donald Trump. Again, while the core concepts of intellectual property maximalism didn't necessarily originate with the United States (and in some areas, we've actually been laggards), there's no denying that over the last few decades, the US has mainly been the strongest supporter of putting such rules into all sorts of international trade agreements (or using those agreements to expand patent and copyright laws even beyond what we currently have in the US).

However, with a President who is extremely skeptical of international trade agreements (even if for the wrong reasons), Stiglitz has decided that it's a potential opportunity. His recent comments in South Africa make that clear. After criticizing Trump, he went on to note the opportunity:

He said developing countries must use the Trump administration as an opportunity to realise that the US hasn’t played the global leadership role it claims to have and take the initiative to negotiate new systems of globalisation, such as reforming intellectual property laws that benefit large corporates at the expense of social welfare.

Speaking out in South Africa is timely, since the country is considering a new patent law that would increase access to drugs that have been cost-prohibitive due to patents.

Stiglitz... welcomed South Africa’s draft changes and urged the country to continue working on the paper. “Any intellectual property regime has to get a balance on innovation on the one hand and dissemination on the other,” he said.

“You should be very concerned about anything that impedes competition,” said Stiglitz, warning South Africa and other developing countries of assisting corporations like big pharmaceutical companies to establish monopolies that don’t benefit local health systems or economic growth.

“There’s a whole history of using intellectual property law to try to squelch innovation,” he said.

While I hope I'm wrong, I'm skeptical that most countries will be willing to embrace a total rethink of intellectual property systems and the problems they cause for innovation -- but it will be worth paying attention to see if other countries do start pushing back on these outdated regimes.

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]]>go-for-ithttps://www.techdirt.com/comment_rss.php?sid=20171119/23322238646Wed, 21 Jun 2017 13:20:29 PDTWhite House Plan To Reduce Drug Prices... Is To EXTEND Patents?Mike Masnickhttps://www.techdirt.com/articles/20170620/00213937625/white-house-plan-to-reduce-drug-prices-is-to-extend-patents.shtml
https://www.techdirt.com/articles/20170620/00213937625/white-house-plan-to-reduce-drug-prices-is-to-extend-patents.shtml
While Congress is still doing its thing to try to make the US healthcare system an even bigger laughingstock around the world, the White House is apparently considering an executive order targeting high drug prices. Of course, it handed this power over to Joe Grogan, a (very recent) former lobbyist for a giant pharma company, Gilead, that has been at the center of some controversy over its highly priced drugs. Grogan is apparently leading this effort despite not having an ethics waiver, which means he's supposed to recuse himself from these discussions, rather than lead them. But, you know, that's not happening in the swampy, swampy waters of Washington DC. So just what would Grogan suggest as a way to lower drug prices? How about extending pharmaceutical patents? Yes. Extending.

The documents reveal behind-the-scenes discussions influenced by the pharmaceutical industry. Joe Grogan, associate director of health programs for the Office of Management and Budget (OMB), has led the group. Until March, Grogan served as a lobbyist for Gilead Sciences, the pharmaceutical company that priced its hepatitis C drugs at $1,000 per pill.

To solve the crisis of high drug prices, the group discussed strengthening the monopoly rights of pharmaceuticals overseas, ending discounts for low-income hospitals and accelerating drug approvals by the Food and Drug Administration. The White House declined to comment on the working group.

In what world does anyone with even the slightest economic knowledge think that extending/expanding monopoly powers would bring prices down rather than up? Want to know one of the reasons why drugs are so crazy expensive right now? It's because those monopoly rights have already gone way too far. If you want lower prices, you want competition in the market, not monopoly suppliers who know they're dealing with major health issues -- and the willingness of insurance companies to pay through the nose.

You can criticize all sorts of things about the way healthcare is handled in this country, or how drug prices are determined. But, it's impossible to see how anyone with a straight face could possibly claim that increasing patent rights would lead to lower prices. Of course, the argument here is effectively that by making patent powers greater overseas, the big pharma companies can milk foreigners for higher drug prices... which would make it easier for them to drop drug prices at home. Here are the details from the report:

Extending the patent life of drugs in foreign markets to “provide for protection and enforcement of intellectual property rights.” This will ensure “that American consumers do not unfairly subsidize research and development for people throughout the globe.”

Except, raise your hand if you think that drug companies would voluntarily lower drug prices in the US, just because they can now also price gouge sick people in other countries? Yeah, didn't think so. If you want to lower drug prices, the way to do it is to cut back the monopoly powers of Big Pharma so that they're actually forced to compete more. This isn't a theoretical or academic claim. Just look at the price of drugs after one goes off patent. They immediately drop. Want cheaper drugs? Ditch the patents and watch the market do its thing.

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]]>that's-not-how-it-works-at-allhttps://www.techdirt.com/comment_rss.php?sid=20170620/00213937625Tue, 18 Oct 2016 09:40:54 PDTHow Pharmaceutical Companies Are Keeping Americans From Doing Something The Government Says They Can DoTim Cushinghttps://www.techdirt.com/articles/20161009/05241535751/how-pharmaceutical-companies-are-keeping-americans-doing-something-government-says-they-can-do.shtml
https://www.techdirt.com/articles/20161009/05241535751/how-pharmaceutical-companies-are-keeping-americans-doing-something-government-says-they-can-do.shtml
The EFF's series on "shadow regulation" continues, this time exploring how American pharmaceutical companies are keeping affordable medication out of the hands of Americans. The examination goes beyond what's already common knowledge: that patents and regulatory capture have created a skewed marketplace that ensures healthy profit margins, rather than healthy Americans.

But what's not generally known is that the pharmaceutical companies have "partnered" with internet intermediaries to lock Americans out of purchasing options specifically approved by the FDA. To hear big pharmaceutical companies tell it, purchasing drugs from other countries (where the price is generally lower) is extremely dangerous, if not completely illegal. But that's simply not true.

[D]iscretionary guidelines developed by the Food and Drug Administration (FDA) and enforced by the CBP allow American consumers to import a 90-day supply of some prescription medications for personal use, including by bringing them across border checkpoints in personal luggage, or by mailing them from overseas. In the latter case, a large market exists for pharmacies registered in other countries such as Canada, Australia and Turkey, that will accept online orders and mail genuine pharmaceuticals to American consumers at cheaper than local prices.

Multiple industry groups -- most of them using the word "safe" in their names to insinuate that purchasing drugs anywhere but where they want you to is inherently "dangerous" -- have blacklisted certain foreign sellers and have pushed for internet service providers to enforce the blacklists.

The Alliance for Safe Online Pharmacies (ASOP) and Center for Safe Internet Pharmacies (CSIP) are two of these groups. Both groups feature a lot of overlapping membership but having two separate organizations gives this the appearance of more membership diversification than there actually is. While there's nothing inherently bad about wanting to ensure Americans purchase legitimate medications from foreign vendors, the blacklists cover more than just questionable sellers.

Two registers of online pharmacy websites are approved by both the ASOP and the CSIP. These are run respectively by LegitScript, and by the National Association of Boards of Pharmacy (NABP) under the name Verified Internet Pharmacy Practice Sites (VIPPS). A third, independent register is run by the eponymous PharmacyChecker.com, which the ASOP and the CSIP do not recognize. This is because while all three exclude sellers of fake and counterfeit drugs from their approved lists, only the U.S. pharmaceutical industry-run registers LegitScript and VIPPS also exclude overseas online pharmacies that supply genuine drugs to Americans under the FDA's personal use policy.

The shadow regulation keeps American purchasers away from legitimate sellers with lower prices. Going forward, ICANN's domain name registration is going to further prevent Americans from accessing more affordable drugs. These groups have pressured ICANN into using the same skewed blacklist when approving .pharmacy domains. While there are still other top-level domains available that may also help bring customers to legitimate vendors these groups want to lock out of the market, that too may change in the coming months. The National Association of Boards of Pharmacy (NABP) wants ICANN to police the web for it and, hopefully, to shut down domains owned by foreign medical vendors it doesn't like.

If it can't force ICANN to bend to its will, it will use tools it already has in place: pressuring online payments providers and ad services to cut off support for any seller it hasn't whitelisted.

This all helps ensure the industry can sell you drugs at the price it wants, rather than the price the market defines. Somehow, the exact same medicine produced by the exact same company should cost more simply because an American pharm tech put it into a bottle and printed a label, rather than someone who lives outside US borders.

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]]>taking-options-awayhttps://www.techdirt.com/comment_rss.php?sid=20161009/05241535751Wed, 12 Oct 2016 03:10:52 PDTAntitrust Suit Alleges Pharma Company Rubbished Its Own Product In Order To Stave Off Competition From GenericsGlyn Moodyhttps://www.techdirt.com/articles/20161007/08174935737/antitrust-suit-alleges-pharma-company-rubbished-own-product-order-to-stave-off-competition-generics.shtml
https://www.techdirt.com/articles/20161007/08174935737/antitrust-suit-alleges-pharma-company-rubbished-own-product-order-to-stave-off-competition-generics.shtml
Techdirt has written a number of stories about how Big Pharma is never content with the patent bargain -- that, in return for a time-limited, government-enforced intellectual monopoly, products will afterwards enter the public domain. Instead, companies have come up with various schemes to extend the life of that monopoly -- and thus to cheat the public of the low-cost generic versions of the drug in question that should have appeared. The Daily Beast points to an antitrust lawsuit brought by 35 states and the District of Columbia against the makers of Suboxone, a prescription drug used to treat opioid addiction, over the alleged use of one such scheme, known as "product hopping". That's where:

a company makes modest changes to a product to extend its patent protections so that other companies cannot enter the market and offer less-expensive generic alternatives.

In this particular example:

Reckitt Benckiser Pharmaceuticals, Inc. -- now known as Indivior PLC -- and MonoSol Rx are accused of conspiring to switch Suboxone from a tablet version to a film, which dissolves in the mouth, in order to prevent or delay generic alternatives and maintain artificially inflated profits.

...

Over time, the states allege that Reckitt converted the market away from the tablet to the film through marketing, price adjustments and other methods. Ultimately, after the majority of Suboxone prescriptions were written for the film, Reckitt removed the tablet from the U.S. market.

The company received an analysis of data from U.S. Poison Control Centers on September 15, 2012 that found consistently and significantly higher rates of accidental unsupervised pediatric exposure with Suboxone Tablets ... than seen with Suboxone Film ... The rates for Suboxone Tablets were 7.8-8.5 times greater depending on the study period.

Curiously, though, Reckitt didn't mention that the study had been commissioned by itself, as the Guardian noted in an article at the time. Quite why Reckitt would want to pay for and then publicize a study that showed one of its own products was dangerous became clearer just a few hours later, when it submitted a "citizen petition" to the Food and Drug Administration:

urging the US regulator to ban any future competitor pills to its suboxone tablets that were insufficiently "child resistant".

In other words, Reckitt effectively wanted the FDA to ban any generic versions of its own tablets, now out of patent, while leaving its patented film formulation on the market to enjoy a new monopoly. As the Guardian reported:

A company spokesman has insisted commercial motives played no part in Reckitt's decision to withdraw suboxone tablets from the market. However, Martin Deboo, an analyst at Investec Securites said: "We view these moves as consistent with Reckitt's strategy of protecting the suboxone franchise by hastening migration to [strip] and raising barriers to entry to generics."

that federal and state healthcare programs, including Medicaid, as well as consumers and other purchasers have paid artificially high monopoly prices since late 2009, when generic alternatives of Suboxone might otherwise have become available. During that time, annual sales of Suboxone topped $1 billion and, since then, rates of opioid abuse in Connecticut and across the country have increased significantly.

That's a useful reminder that pharma patents are not just about monopolies and money, but also about people and pain.

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]]>commercial-motives-played-no-parthttps://www.techdirt.com/comment_rss.php?sid=20161007/08174935737Tue, 7 Jun 2016 17:00:00 PDTDailyDirt: Antibiotic Resistance Is (Not) Futile...Michael Hohttps://www.techdirt.com/articles/20110718/11193615149/dailydirt-antibiotic-resistance-is-not-futile.shtml
https://www.techdirt.com/articles/20110718/11193615149/dailydirt-antibiotic-resistance-is-not-futile.shtmlfound in the US, there's a bit of concern that medicine could regress significantly in the face of uncontrollable bacteria. We've had antibiotic drugs for about 70 years now, and we've grown accustomed to the effectiveness of these drugs. Hopefully, we can stay ahead of drug-resistant microbes with new pharmaceuticals or phage therapy.

After you've finished checking out those links, take a look at our Daily Deals for cool gadgets and other awesome stuff.

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]]>urls-we-dig-uphttps://www.techdirt.com/comment_rss.php?sid=20110718/11193615149Fri, 11 Mar 2016 03:27:00 PSTIndia Finally Bows To US Pressure: Promises Not To Use Compulsory Licensing For DrugsGlyn Moodyhttps://www.techdirt.com/articles/20160308/09432133833/india-finally-bows-to-us-pressure-promises-not-to-use-compulsory-licensing-drugs.shtml
https://www.techdirt.com/articles/20160308/09432133833/india-finally-bows-to-us-pressure-promises-not-to-use-compulsory-licensing-drugs.shtml
Techdirt has been covering India's complex relationship with pharma patents since at least 2009. In particular, we've been following for years India's use of compulsory licenses to provide its people with access to life-saving drugs at affordable prices. Naturally, Big Pharma companies in both the US and EU hate that, not least because it might encourage other countries to do the same. As a result, the US pharmaceutical industry in particular has been applying political pressure to get India to stop using compulsory licenses, even though they are a perfectly legitimate policy tool under the WTO TRIPS Agreement. Two years ago, Techdirt noted that India was already becoming more cautious on the compulsory licensing front, and a new report from Reuters suggests it may finally have bowed to US pressure:

India has given private assurances that it will not grant licences allowing local firms to override patents and make cheap copies of drugs by big Western drugmakers, a U.S. business advocacy group said.

The comments were revealed in a submission last month by the U.S.-India Business Council (USIBC) to the U.S. Trade Representative (USTR), which is reviewing global intellectual property laws for an annual report identifying trade barriers to U.S. companies.

There's been no official confirmation from the Indian government of that decision, nor an explanation of why it has decided to give in, assuming it has. The Reuters article mentions the fact that India had been placed for two years in a row on the infamous Special 301 Report's "Priority Watch List". That's one of the favorite ways in which PhRMA, the Pharmaceutical Research and Manufacturers of America, tries to bully countries -- or even entire continents -- into doing its bidding. But giving up compulsory licenses just to stay off the Special 301 naughty step seems an incredibly high price to pay, for reasons explained by Knowledge Ecology International (KEI):

"If such an agreement [between the Indian government and the US drug industry] in fact exists, this is extremely troubling news ... this sort of pressure is basically a declaration of war on poor cancer patients," KEI said in its own submission to the USTR last week.

Given the USIBC document that Reuters says it has seen, it seems likely that the Indian government has indeed given some sort of assurance to the US companies. But the fact that it has been kept quiet shows that the politicians are fully aware of how unpopular the move will be once the Indian public finds out about it. That provides some hope the policy could be reversed if enough people in India start complaining, as happened recently with software patents.

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]]>declaration-of-war-on-poor-cancer-patientshttps://www.techdirt.com/comment_rss.php?sid=20160308/09432133833Wed, 30 Dec 2015 17:00:00 PSTDailyDirt: Imagine There's No Cancer...Michael Hohttps://www.techdirt.com/articles/20110318/12132313551/dailydirt-imagine-theres-no-cancer.shtml
https://www.techdirt.com/articles/20110318/12132313551/dailydirt-imagine-theres-no-cancer.shtml2015, an estimated 1.6 million patients were diagnosed with cancer and over half a million died from it. We've previously pointed out some cancer research that could lead to promising new treatments, and it looks like we're making significant progress in the fight against the many forms of this deadly disease. Using the body's own immune system to fight cancer is a growing strategy that seems to be working. Check out a few of these minor successes.

After you've finished checking out those links, take 10% off any $50+ order from our Daily Deals using the promo code DAILYDIRT.

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]]>urls-we-dig-uphttps://www.techdirt.com/comment_rss.php?sid=20110318/12132313551Thu, 3 Dec 2015 10:38:00 PSTExpress Scripts Pushing $1 alternative To Turing's $750 Daraprim PillsKarl Bodehttps://www.techdirt.com/articles/20151202/06251232965/express-scripts-pushing-1-alternative-to-turings-750-daraprim-pills.shtml
https://www.techdirt.com/articles/20151202/06251232965/express-scripts-pushing-1-alternative-to-turings-750-daraprim-pills.shtmlhiding it ahead of the Thanksgiving holiday in the hopes that fewer people would notice (it worked relatively well). CEO Martin Shkreli, you'll recall, increased the price for Daraprim from $13.50 per pill to $750 -- a 5000% or so mark up for a sixty-two-year-old medication. Shkrelli brought renewed attention to the skyrocketing prices of generics thanks to (ab)using restricted distribution to deny samples to generics manufacturers.

But there may be a small ray of sunshine in what's an otherwise dismal tale of greed. Prescription drug manager Express Scripts has indicated that the company will soon promote use of a compounded medicine that contains the same active ingredient as Daraprim, and offer it at a fraction of the price. Express Scripts manages prescriptions for tens of millions of Americans and will be pushing the compounded alternative made by Imprimis Pharmaceuticals. The new compounded alternative includes Daraprim’s active ingredient, pyrimethamine, as well as leucovorin, included to treat side effects.

"Compounded drugs are customized formulations made by pharmacies for particular, named patients. That requirement restricts how directly Imprimis can compete with Turing. For instance, hospitals cannot stock the compounded version to use for patients coming to the emergency room.

Imprimis, which is publicly traded, is not allowed to make a direct copy of Daraprim. So its capsule contains both pyrimethamine and leucovorin, a drug that is often prescribed with Daraprim to ease certain side effects. If a doctor writes a prescription for Daraprim, Express Scripts or pharmacies cannot substitute the compounded drug produced by Imprimis. So physicians will have to write a prescription specifically for the compounded drug and fax it to Imprimis."

It's a bit of a cumbersome tap dance (so glad we're still using faxes in the age of gigabit fiber), but at least it's an alternative. Impremis has stated it plans to offer the compounded drug for as low as 100 capsules for $99. Express Scripts in turn will help speed delivery of the cheaper option, working with the Infectious Diseases Society of America and the HIV Medicine Association to inform medical professionals about the alternative. Turing has so far responded by telling media outlets that "in addition to being potentially unsafe and ineffective, the compounded product is unnecessary."

Granted, the actual impact may still be low; Express Scripts states it only had 350 patients who used Daraprim last year. Still, it's the principle of the thing, and it's nice to see the market -- even if it has to jump through hoops to do so -- giving Shkreli and Turing a few quick kicks to the shins.

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]]>almost-competitionhttps://www.techdirt.com/comment_rss.php?sid=20151202/06251232965Wed, 25 Nov 2015 09:32:00 PSTTuring Refuses To Lower Cost Of Daraprim, Hides News Ahead Of Thanksgiving HolidayKarl Bodehttps://www.techdirt.com/articles/20151125/06031232900/turing-refuses-to-lower-cost-daraprim-hides-news-ahead-thanksgiving-holiday.shtml
https://www.techdirt.com/articles/20151125/06031232900/turing-refuses-to-lower-cost-daraprim-hides-news-ahead-thanksgiving-holiday.shtmland mankind -- he was feebly defending his company's decision to jack up the price of a 60-year-old medication some 5000%. Shkreli became America's least liked human being after his company increased the price per pill of Daraprim (used by both AIDS and cancer patients) from $13.50 per pill to $750 per pill. After relentless criticism, Shkreli appeared to backpedal, claiming last September the company would lower prices:

"We’ve agreed to lower the price on Daraprim to a point that is more affordable and is able to allow the company to make a profit, but a very small profit,” he told ABC News. “We think these changes will be welcomed."

Yeah, or not.

Hoping to bury any criticism ahead of the Thanksgiving holiday, Turing released a dodgy press release on Wednesday implying the company had finally seen the error of its ways and would be reducing the cost of Daraprim. Except it's not actually doing anything of the sort. While the company will offer hospitals a 50% discount (now only a 2500% mark up) and is engaging in a few superficial efforts most companies already offer via their patient assistance programs, the press release buries the lede in that the core price of Daraprim isn't going anywhere.

And, just to add insult to injury, a company spokesman insists that's a good thing because (I kid you not) lower drug prices don't benefit patients:

"Drug pricing is one of the most complex parts of the healthcare industry. A drug's list price is not the primary factor in determining patient affordability and access. A reduction in Daraprim's list price would not translate into a benefit for patients."

There's nothing complex about being a raging asshole. There's also nothing complex about a former hedge fund manager jacking up the price of an essential drug 5000% (as is happening with many previously-inexpensive generics), pretending he'd seen the error of his ways, then feebly trying to hide his total lack of integrity ahead of a long holiday weekend.

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]]>the absolute worsthttps://www.techdirt.com/comment_rss.php?sid=20151125/06031232900Tue, 10 Nov 2015 03:17:00 PSTUK Health Minister Filibusters Bill To Use Off-Patent Drugs To Provide Effective New Treatments At Low CostGlyn Moodyhttps://www.techdirt.com/articles/20151108/07224932753/uk-health-minister-filibusters-bill-to-use-off-patent-drugs-to-provide-effective-new-treatments-low-cost.shtml
https://www.techdirt.com/articles/20151108/07224932753/uk-health-minister-filibusters-bill-to-use-off-patent-drugs-to-provide-effective-new-treatments-low-cost.shtml
Here on Techdirt we often write about pharmaceutical companies doing what they can to string out their drug monopolies as long as possible, sometimes resorting to quite extraordinary approaches. But whatever tricks they use to extend their monopolies, one day those end, and at that point generic manufacturers can make the drug in question without needing a license. You'd think governments would be delighted by the downward pressure this exerts on prices, since it means that they can provide life-changing and life-saving treatments much more cheaply. But last week, we had the bizarre spectacle of a UK government health minister filibustering a Bill that would have encouraged doctors to prescribe more off-patent medicines. As the Independent newspaper reports:

A Conservative health minister has deliberately blocked a new law to provide cheap and effective drugs for the [UK's National Health Service] by championing medicines whose patents have expired.

Alistair Burt spoke for nearly half an hour to "filibuster" the proposed Off-Patent Drugs Bill, a plan that had cross-party support from backbenchers.

The Off-Patent Drugs Bill attempted to address a particular problem that off-patent drugs suffer from. Although anyone can manufacture and sell them for their original purpose, more innovative uses require a new license for that application. Since the drugs are off-patent, the profit margins are lower, and generic manufacturers are reluctant to pay for the re-licensing process. An article in the online law journal "Keep calm and talk law", reporting on an earlier unsuccessful attempt to have off-patent drugs used more widely, gave the following examples of how cheap drugs could have a major impact:

Simvastatin was originally licensed for treating individuals with high cholesterol and although recently shown to slow brain atrophy in later stages of multiple sclerosis by over 40 per cent, it has not been relicensed for that purpose. Further, Lixisenatide and liraglutide, two common diabetes drugs, have been found to have a use in the prevention of Alzheimer's but is now also off patent.

The Bill in question would have required the UK government to carry out the re-licensing, thus allowing generic manufacturers to market the cheap off-patent drugs for new treatments. But the UK government minister rejected this approach, saying "there is another pathway", without spelling out what that might be. Perhaps he had in mind the possibility of prescribing off-patent drugs "off label", which in theory is an option open to UK doctors. But doing so means they would assume the legal responsibility for both negligent and non-negligent harm to the patient -- something that many are understandably reluctant to do. However, the "Keep calm and talk law" article offers a possible solution to that problem:

the introduction of a charitable organisation which would insure doctors against any negligence claims resulting from the prescription of specified off-patent drugs for unlicensed purposes. This could reassure doctors enough that they would more readily prescribe some useful off-patent drugs such as the examples given above. Although much research would still need to be done into whether a charity such as this could work in reality, in principle this is a solution which seems sensible.

It's possible that the UK government minister had precisely this approach in mind when he unceremoniously blocked a Bill that was trying to save both lives and money. But it's hard not to suspect that his "another pathway" might turn out to involve lots more lucrative pharma patents instead.

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]]>and-why-on-earth-would-he-do-that?https://www.techdirt.com/comment_rss.php?sid=20151108/07224932753Fri, 23 Oct 2015 12:45:21 PDTCompetitor Steps In To Offer Toxoplasmosis Drug For $749 Less Per Pill Than Martin Shkreli And Turing PharmaTim Cushinghttps://www.techdirt.com/articles/20151023/11071832609/competitor-steps-to-offer-toxoplasmosis-drug-749-less-per-pill-than-martin-shkreli-turing-pharma.shtml
https://www.techdirt.com/articles/20151023/11071832609/competitor-steps-to-offer-toxoplasmosis-drug-749-less-per-pill-than-martin-shkreli-turing-pharma.shtml
When Turing Pharmaceuticals jacked up the price of a toxoplasmosis-fighting drug (commonly used by AIDS and cancer patients) to $750/pill (a previous company sold it for $1/pill), CEO Martin Shkreli defended the move, saying the money would be dumped into research for a new and better drug. Of course, this is the usual defense offered by any pharmaceutical company that institutes a rate hike, but these claims are rarely followed through on. (And when they are, the R&D costs tend to be very overstated.)

Daraprim has been on the market since the 1950s and does its job well. The patent has long expired but the FDA's policies make it difficult for anyone to formulate a generic version of this "sole supplier" drug. When there's no competition, it's a seller's market, and Martin Shkreli is making the most of it.

Turing CEO Martin Shkreli became “the most hated man in America” last month after raising the cost of the drug, commonly used to treat parasitic infections in immunocompromised patients, from $13.50 per pill to a staggering $750 per dose, claiming the company’s exorbitant price hike was justified. Now Imprimis will offer their alternative to those who need Daraprim for less than $1 per tablet.

Imprimis is now offering customizable compounded formulations of pyrimethamine and leucovorin in oral capsules starting as low as $99.00 for a 100 count bottle, or at a cost of under a dollar per capsule. Compounded medications may be appropriate for prescription when a commercially-available medicine does not meet the specific needs of a patient.

There's more detail in the disclaimer towards the end of the press release.

Imprimis' finished compounded drug formulations do not have an FDA-approval label for recommended use. Imprimis compounded formulations are not FDA approved and may only be prescribed pursuant to a physician prescription for an individually identified patient consistent with federal and state laws governing compounded drug formulations.

So, those looking for a cheaper variant of Daraprim will have to find a physician willing to prescribe a drug that doesn't have the FDA's blessing for this particular use. The compound will likely work as well as Daraprim, but it does open doctors up to additional liability. That being said, some doctors may be willing to do this as the only other option for some patients will be no medicine at all.

The other problem is that the FDA could come down aggressively on pharmaceutical companies who market drugs for non-FDA-approved purposes. Imprimis is exploiting a loophole in the system, albeit one much more easily closed than the FDA's loophole-esque sheltering of "sole supplier," off-patent drugs -- the sort that most often see astronomical price hikes post-acquisition.

But for now, it's the market system at work -- the same market system Shkreli used as a justification for raising Daraprim's price. Zero competition led to Turing's $750/pill price. A little competition might push Shkreli to drop Daraprim's retail price lower than he actually wanted to. (And, again, no price drop has been instituted at this point.) But given Shkreli's past use of the FDA as his unofficial partner in stock-shorting moves, it's far more likely he'll be asking the agency to eject his new competitor from the playing field.

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]]>so-much-for-the-'it's-only-profitable-if...'-argumenthttps://www.techdirt.com/comment_rss.php?sid=20151023/11071832609Tue, 13 Oct 2015 10:43:55 PDTUS, Australia & Canada Decide Screw Over Poor Nations Because Big Pharma's Not Happy With TPPMike Masnickhttps://www.techdirt.com/articles/20151012/17380532517/us-australia-canada-decide-screw-over-poor-nations-because-big-pharmas-not-happy-with-tpp.shtml
https://www.techdirt.com/articles/20151012/17380532517/us-australia-canada-decide-screw-over-poor-nations-because-big-pharmas-not-happy-with-tpp.shtmlalmost everything it wanted in the agreement, but wasn't quite able to get a few things, including a 12 year patent-like exclusivity on biologics. And, because of that hissy fit, apparently, the USTR and its counterparts in Australia and Canada have agreed to help out Big Pharma in another arena. Jamie Love is reporting that this week there's a meeting at the WTO this week to explore granting a special exemption on patent rules for developing nations (i.e., those who often need drugs the most, while also being the least likely to be able to afford them). It's silly to enforce patents in these countries, because doing so would not only lead to almost no business at all, but (more importantly) because lots of people will die or, at the very least, suffer needlessly.

On Friday, 9 October 2015, Ambassador Punke met with representatives from 15 countries (including 5 Ambassadors) from the LDC Group. Ambassador Punke clearly indicated that the US could not agree on an indefinite exemption because certain stakeholders in the United States were quite upset with concessions made by USTR during the final stages of the Trans-Pacific Partnership (TPP). Informed sources noted that the US indicated that "the TPP did not deliver as expected on IP and so we are under a lot of pressure not to give in more on IP."

How far the pharma industry has come from the days when George Merck declared: "We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been."

And, really, how do the folks who work at the USTR sleep at night knowing that they're doing this for no reason other than to help out the profits of a few giant companies at the expense of the public?

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]]>isn't-that-nicehttps://www.techdirt.com/comment_rss.php?sid=20151012/17380532517Wed, 23 Sep 2015 17:00:00 PDTDailyDirt: Breaking Bad... With Yeast?Michael Hohttps://www.techdirt.com/articles/20101126/16165912019/dailydirt-breaking-bad-with-yeast.shtml
https://www.techdirt.com/articles/20101126/16165912019/dailydirt-breaking-bad-with-yeast.shtmlyeast can produce a bunch of useful stuff, beyond bread and beer. Synthetic biology promises to give us engineered microorganisms that can make almost any specialty chemical or even some biofuels. Brewing medicine might not be too far away, and it might be incredibly difficult to control "controlled substances" in the very near future.

After you've finished checking out those links, take a look at our Daily Deals for cool gadgets and other awesome stuff.

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]]>urls-we-dig-uphttps://www.techdirt.com/comment_rss.php?sid=20101126/16165912019Wed, 23 Sep 2015 03:32:00 PDTTuring Pharma Caves; Says Drug Price Will Move In Generally Downward Motion At Some Point In The FutureTim Cushinghttps://www.techdirt.com/articles/20150922/19344332338/turing-pharma-caves-says-drug-price-will-move-generally-downward-motion-some-point-future.shtml
https://www.techdirt.com/articles/20150922/19344332338/turing-pharma-caves-says-drug-price-will-move-generally-downward-motion-some-point-future.shtml
Martin Shkreli -- who became the personification of a deeply-reviled industry thanks to his insanely-exorbitant price hike on a 60-year old drug -- has heard the disapproving roar of the crowd and will do… something… at some point in the future… to make things right. Or at least a bit more right-ish.

“We’ve agreed to lower the price on Daraprim to a point that is more affordable and is able to allow the company to make a profit, but a very small profit,” he told ABC News. “We think these changes will be welcomed.”

With nothing else to go on (other than Shkreli's continued assertions that the drug is still underpriced), the public will just have to assume that the new price point, whenever it arrives, will be barely above cost. (Considering it was produced for a $1/pill before Turing's purchase, one would think a significant reduction in price would still leave plenty of room for profits and additional R&D.)

Turing's mini-debacle has damaged the pharmaceutical industry. It has drawn even more heat from legislators and presidential candidates. It has even negatively affected more tangible aspects, like stock prices. Shkreli's actions have also drawn attention to the oft-ignored regulatory procedures that allow companies to fully exploit old drugs and medications, even without the protective power of active patents. Derek Lowe at Science Magazine explains the route to securing post-patent monopolies.

By various means, old generic compounds have ended up as protected species, and several companies have made it their business to take advantage of these situations to the maximum extent possible. The FDA grants market exclusivity to companies that are willing to take “grandfathered” compounds into compliance with their current regulatory framework, and that’s led to some ridiculous situations with drugs like colchicine and progesterone. (Perhaps the worst example is a company that’s using this technique to get ahold of a drug that’s currently being provided at no charge whatsoever).

Combine this with the bottleneck Turing generously refers to as "distribution" (via a single specialty pharmacy or directly from Turing itself) and you have everything you need to demand any amount you want for a lifesaving drug with a limited market. Everything being said about R&D investment is just smoke until proven otherwise.

Following his short statements promising unquantified price drops at an unspecified point in the future, Martin Shkreli -- who seemed to relish praising himself/insulting his detractors from this social media platform -- took his Twitter ball and went home.

Turns out the market will bear far less than Turing thought, even with the benefits of a tightly-controlled distribution chain and the FDA's assistance in keeping competitors off the playing field. A whole lot of people who will never use the drug managed to nudge the price downward, and all within 48 hours.

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]]>and-will-only-do-so-because-the-public-doesn't-understand-businesshttps://www.techdirt.com/comment_rss.php?sid=20150922/19344332338Tue, 22 Sep 2015 13:54:44 PDTTuring Pharma Boss Martin Shkreli Defends Massive Price Increase As A Good Thing For PatientsTim Cushinghttps://www.techdirt.com/articles/20150922/09393232328/turing-pharma-boss-martin-shkreli-defends-massive-price-increase-as-good-thing-patients.shtml
https://www.techdirt.com/articles/20150922/09393232328/turing-pharma-boss-martin-shkreli-defends-massive-price-increase-as-good-thing-patients.shtml
Martin Shkreli -- founder of Turing Pharmaceuticals and overnight poster boy for everything that is wrong with the pharmaceutical industry -- spent a lot of yesterday defending his 5000% price hike on Daraprim, a drug that treats victims of toxoplasmosis. That the drug has a nexus with cancer and AIDS sufferers (basically anyone with a diminished immune system) made the price increase seem even more unconscionable.

Dr. Wendy Armstrong, professor of infectious diseases at Emory University, questions Turing’s claim that, after more than 60 years of physicians using Daraprim, there is a need for a better version of the drug.

“I certainly don’t think this is one of those diseases where we have been clamoring for better therapies,” says Armstrong.

Next, there's the inherent ridiculousness of this assertion, which portrays Turing's plans for Daraprim as a reverse pyramid scheme, in which future "investors" will benefit from the gouging of those who got in on the ground floor.

On top of that, Shkreli claims the drug is still underpriced, despite having been sold for $1/pill before its acquisition by the company Turing acquired it from.

While it's true that drug research and development can be expensive, it is nowhere near as costly as this price hike would indicate. Shkreli tossed out the easily-debunked claim that it costs $1 billion to bring a new drug to market. The actual cost is considerably lower (~$55 million), according to research using the same data drug companies provided to backup their claims of $1.3 billion in R&D costs per new drug.

Data also shows pharmaceutical companies spend far more on marketing than research and development. They have to. Most "new" products on the market aren't actually new. They're just variants on what's already available. It's tough to sell a "new" drug that doesn't outperform a competing product, hence the increased marketing expenditures.

Shkreli also used a variant of "everyone else is doing it" to defend the price jump. He pointed to the existence of other cancer drugs costing "over $100,000" per treatment as justifying Turing's price increase. But being slightly less exortionate than competitors isn't the same thing as being "good."

Shkreli has little interest in being good, no matter what altruistic assertions he makes. His former company -- from which he was ousted over accusations of stock price manipulation -- also jacked up the price on an essential drug just because it could.

When Retrophin acquired rights to Thiola, the drug cost about $1.50 per pill. [Patients take multiple pills per day.] Now, Retrophin has decided to charge more than $30 for the same Thiola pill. Retrophin says it has plans to change the Thiola dose and develop an extended release version of the drug, but I have seen none of those changes yet. To my knowledge, Retrophin hasn't yet done any of this work -- except to drastically increase Thiola's price.

And indeed, Retrophin never did. From a 2015 presentation, it's generating sales for Retrophin, but nowhere in it is any indication the company is actually working towards an extended-release version of the drug.

I asked Shkreli about this and he claimed the company ditched the R&D plans after it ousted him. Maybe this is true, but it doesn't exactly instill any confidence in Shkreli's latest claims that price hikes are being done with an eye on increased R&D spending. Instead, they look like nothing more than the normal deflection performed by drug companies after controversial price increases.

Other circumstantial evidence does little for consumer confidence. Not only is Shkreli being sued by his former company for fraudulent behavior, he's previously been taken to court (by Lehman Brothers) for a $2.3 million loss he incurred (but never repaid) when his bet on a market decline went south. The complaint accuses him not only of failing to pay Lehman what was owed, but of pushing through the transaction without actually possessing the funds to cover the original purchase.

Shkreli also has a history of thriving on market failure. He has made money shorting pharmaceutical stocks while simultaneously engaging in questionable behavior. Here's a "treatise" he wrote detailing the negative aspects of one company's research efforts, which clearly states at the top of each page (for legal reasons) that he stands to personally gain if the company's stock price drops.

DISCLAIMER: The authors of this article have a conflict of interest and will benefit financially if the stock price of VTL falls. The authors reserve the right to change their investment if the price of VTL changes dramatically. Please read the Disclosure at the end of this paper for more information.

(This was tracked down from a deleted tweet by Martin Shkreli. Other Twitter users had commented on it, so it was recoverable from Google cache. Here's a screenshot, because the cache won't stay live for long.)

But he's also been accused of actions that are more than simply treading the edge of legality. A heated Twitter exchange implies Shkreli talked the FDA out of a drug approval -- something that hurt the company producing the drug, but paid off for Shkreli's stock short.

Shkreli's history does little to back up his assertions of altruistic goals and a future full of well-funded research and development. Instead, it shows someone who's willing to exploit every last dollar out of something and leave its dessicated corpse behind.

On top of that, share prices for several drug companies fell the day the Daraprim price hike went viral. That this may have worked out well for Shkreli can't be ignored, considering his prior experience with shorting pharmaceutical companies. Maybe this was part of the plan: Short pharma stocks. Jack price up on newly-acquired drugs. Play the villain while cashing in on the market decline.

That's all speculation, of course. What is certain is that Martin Shkreli is not THE problem. (He's not even "Big Pharma," even though several editorials have placed him in this group.) He's part of the problem, but his specific actions are more about exploiting obscure drugs that competitors aren't interested in. His actions shed little light on the genesis of high drug prices.

The original issue is patents. That has been mostly ignored by legislators and opinion pieces during the most recent push for some sort of drug pricing controls. And it will continue to be ignored because Daraprim's price hike is completely unrelated to patent monopolies. Turing's exclusive license for Daraprim includes only the use of the trademarked name. The patents have expired. Anyone can make it, but no one's been particularly interested in offering an alternative. (Maybe this will change now that a company has a chance to take on the villain du jour…)

But it's patents that make drugs unaffordable in the first place. New drugs are given, at minimum, 20 years of competition-free sales. That's two decades (at least) where drug companies can charge whatever they want because no one else can offer a competing product. Companies -- like Shkreli -- will claim they need this exclusivity to recoup "massive" research and development costs. But this simply isn't true. Pharmaceutical companies enjoy massive profit margins, much more than would be expected if they were faced with meaningful competition. The lie is exposed when patents expire. Prices fall dramatically once the market is opened, including that of the original manufacturer's.

So, if the government really wants to tackle the problem of overpriced drugs, it needs to start with the protections it grants that allow this to happen. But this seems unlikely to happen because drug companies have significant "buying power" when it comes to legislation, no matter how many people come forward to testify about being priced out of essential treatments.

Shkreli, however, is specializing in finding "orphan drugs" -- drugs for rare conditions that are no longer under patent protection (which would raise the acquisition price significantly) but which have seen little to no competitive movement over the years. His decision to implement a 5000% price increase, despite minimal costs (and benefiting from R&D performed 60 years ago), is one he can make because there's no market force in place to stop him. So, he may be the poster boy for everything that's wrong with the pharmaceutical industry, but he's not really indicative of the ongoing problem.

What he is, however, is an opportunist with a hedge fund background and a history of market exploitation. Any claims of altruism or searches for better treatments should be met with intense skepticism.

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]]>just-another-symptom-of-a-diseased-systemhttps://www.techdirt.com/comment_rss.php?sid=20150922/09393232328Thu, 2 Jul 2015 14:49:00 PDTLeaked TPP Chapter Shows How It's A Massive Gift To Big Pharma And Against Public HealthMike Masnickhttps://www.techdirt.com/articles/20150701/17080331520/leaked-tpp-chapter-shows-how-massive-gift-to-big-pharma-against-public-health.shtml
https://www.techdirt.com/articles/20150701/17080331520/leaked-tpp-chapter-shows-how-massive-gift-to-big-pharma-against-public-health.shtmllast October by Wikileaks and was the version from the previous May (2014). Now, Politico claims that someone has leaked the May 2015 version, though Politico has not published the document (which, frankly, is pretty lame for a journalism property). But, based on Politico's report, the agreement still looks to be what everyone's been saying it would be: a huge gift to giant corporate special interests, such as Big Pharma:

The draft text includes provisions that could make it extremely tough for generics to challenge brand-name pharmaceuticals abroad. Those provisions could also help block copycats from selling cheaper versions of the expensive cutting-edge drugs known as “biologics” inside the U.S., restricting treatment for American patients while jacking up Medicare and Medicaid costs for American taxpayers.
“There’s very little distance between what Pharma wants and what the U.S. is demanding,” said Rohat Malpini, director of policy for Doctors Without Borders.

In response, the USTR falls back on its standard lame reply, about how draft texts are not "final." But this is why it's actually important to post these draft texts publicly, because what the draft Politico saw appears to show is that, whether or not it gets it, the USTR is fighting for policies that would harm poor, sick people, and massively benefit giant pharmaceutical conglomerates.

The highly technical 90-page document, cluttered with objections from other TPP nations, shows that U.S. negotiators have fought aggressively and, at least until Guam, successfully on behalf of Big Pharma.

That bit of information seems rather important in determining whose interests the USTR is truly representing in these negotiations. Remember, that while the final agreement will be posted publicly, the negotiating texts (which show what each side argued for) are being kept secret for four yearsafter ratification -- by which point the staff at the USTR will likely have turned over greatly, and whoever is there now can pretend they had nothing to do with the negotiating positions that the US is now locked into.

And, of course, now that fast track is the law, Congress can't even step in to fix it. They'll only be allowed an up/down vote on the entire agreement -- with tremendous pressure on them to approve the whole thing, even if there are dangerous provisions mixed in the overall agreement.

Of course, we all know that this is why the agreement is secret. It's not politically feasible for the US government to publicly show that it's fighting against the health interests of the public and in favor of pharma profits. But it appears that's exactly what's happening behind closed doors. And that seems... wrong.

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]]>but,-fast-track's-in-place,-so-too-bad,-suckershttps://www.techdirt.com/comment_rss.php?sid=20150701/17080331520Fri, 12 Jun 2015 17:00:00 PDTDailyDirt: It's The Yeast I Can Do...Michael Hohttps://www.techdirt.com/articles/20101116/11051011892/dailydirt-yeast-i-can-do.shtml
https://www.techdirt.com/articles/20101116/11051011892/dailydirt-yeast-i-can-do.shtmlhuman insulin can be made using a fermentation process with bio-engineered bacteria. Various kinds of yeast can produce different kinds of breads and beers, but if we can modify these tiny organisms at will, yeast could produce an incredibly wide variety of products. Just check out these links on the versatility of yeast.

After you've finished checking out those links, take a look at our Daily Deals for cool gadgets and other awesome stuff.

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]]>urls-we-dig-uphttps://www.techdirt.com/comment_rss.php?sid=20101116/11051011892Fri, 12 Jun 2015 00:26:16 PDTLeak Of TPP Health Annex Shows New Zealand's Beloved Pharmac System Under Direct AttackGlyn Moodyhttps://www.techdirt.com/articles/20150611/09383431306/leak-tpp-health-annex-shows-new-zealands-beloved-pharmac-system-under-direct-attack.shtml
https://www.techdirt.com/articles/20150611/09383431306/leak-tpp-health-annex-shows-new-zealands-beloved-pharmac-system-under-direct-attack.shtml
After a rather quiet period, WikiLeaks seems to be back on form. After the big TISA leak last week, it's released the Healthcare Annex to the Transparency Chapter of TPP. The document itself is short (pdf), and fairly opaque, so WikiLeaks has helpfully provided some expert commentary from Deborah Gleeson (pdf) and Jane Kelsey (pdf), both well-known academics in this field. Here's a key part of Gleeson's summary:

The inclusion of the Healthcare Transparency Annex in the TPP serves no useful public interest purpose. It sets a terrible precedent for using regional trade deals to tamper with other countries' health systems and could circumscribe the options available to developing countries seeking to introduce pharmaceutical coverage programs in future.

The Annex is clearly intended to target New Zealand’s Pharmaceutical Management Agency (PHARMAC) and some of its provisions will result in new obligations for PHARMAC that will involve transaction costs and could impinge on its flexibility and autonomy. This is particularly worrying given that PHARMAC provides a model pharmaceutical coverage program that is suitable for adoption by developing countries.

Pharmac is New Zealand's system for buying medicines in bulk, which results in substantial savings for the country -- around $3.5 billion since 2000. US drug companies hate it for two reasons: it is able to negotiate lower prices in New Zealand by consolidating purchases for the whole country; and it represents a dangerously successful model that other countries might adopt. The latest leak is important because it confirms that Big Pharma is using TPP not only to strengthen drug patents, but also to attack Pharmac directly.

It has long been a fear that TPP would seek to undermine it, something that the New Zealand government has strenuously denied. The latest clear evidence that Pharmac is indeed under threat has forced the country's prime minister, John Key, to respond, reported here by the New Zealand Herald:

Prime Minister John Key has promised that New Zealanders will continue to pay no more than $5 [US$3] for subsidised prescriptions, whatever happens to Pharmac under the Trans Pacific Partnership.

Jane Kelsey is quoted in the new story as noting that there were only four possibilities:

the Government could increase the health budget overall; the health budget could remain the same but more funding go from non-Pharmac costs to Pharmac; the price the public paid for prescriptions could rise -- which Mr Key ruled out today; and the fourth was that fewer medicines were bought by Pharmac.

Any of the other options means higher taxes in New Zealand or cuts somewhere else to pay for the more expensive drugs TPP is almost certain to bring. That fact has led to a spate of articles in the New Zealand press, and a wider awareness about the negative consequences of the hitherto obscure TPP, albeit rather late in the day.

As a side note, it's worth noting one other interesting aspect, pointed out by Kelsey in her detailed analysis of the latest leak:

The Annex applies very specifically to a 'national health care program' that makes recommendations/decisions about listing pharmaceutical products or medical devices for reimbursement, or the sum of that reimbursement, where these programmes are run by a 'national health care authority'.

The Annex does not apply to direct government procurement of pharmaceuticals and medical devices.

'National' is presumably chosen to preclude such programmes that are run by states and provinces, which are politically sensitive in the US and Canada. In effect, the US has excluded almost all its own programmes, while targeting New Zealand

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]]>do-as-I-say,-not-as-I-dohttps://www.techdirt.com/comment_rss.php?sid=20150611/09383431306Fri, 29 May 2015 04:01:00 PDTFTC Gets $1.2 Billion From Drug Company Over 'Pay For Delay' Patent ScamMike Masnickhttps://www.techdirt.com/articles/20150528/09092231138/ftc-gets-12-billion-drug-company-over-pay-delay-patent-scam.shtml
https://www.techdirt.com/articles/20150528/09092231138/ftc-gets-12-billion-drug-company-over-pay-delay-patent-scam.shtmlpay for delay scam that many pharmaceutical companies have used to effectively pay generic drug makers not to compete with them, even though they are able to do so. The full details of how the scam works are complex, but involve abusing a ridiculous part of the Hatch Waxman Act that grants additional monopoly benefits to the first market entrant of a generic drug. The big pharma firms used that to their advantage, filing bogus lawsuits against those generic drug makers and then agreeing to "settle" the lawsuit they filed by paying the generic drug maker to not actually enter the market. The greater monopoly protection afforded to the big pharma company more than makes up for how much they have to pay the generic drug maker. In short, it's taking advantage of the stupidity of giving drug companies massive monopolies.

The FTC started looking into these practices years ago, and two years ago the Supreme Court ruled that the FTC had every right to go after drug makers using antitrust laws over these "deals." And the FTC has been filing lawsuits on an ongoing basis about these deals.

Teva has now settled one such case for a cool $1.2 billion -- giving you a sense of just how valuable it has been to these pharma companies to extend their monopoly, keep out competition and keep drug prices artificially high. With Teva, it was the sleep disorder drug provigil (and, technically, the drugmaker was Cephalon, which Teva then bought). Teva had been fighting with the FTC for years over this, and the case was scheduled to go to trial next week -- but the settlement ends that. The amount, $1.2 billion, by the way, is the largest ever settlement with the FTC. You have to imagine that there will be more of these coming considering the number of other lawsuits and the fact that "pay for delay" was a widespread practice in the pharma industry.

Of course, even with all of this abuse, some people still insist that giving monopoly rights to pharmaceutical companies is the best way to produce new medicines and to provide healthcare. Isn't it about time we began to question those assumptions?

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]]>one-downhttps://www.techdirt.com/comment_rss.php?sid=20150528/09092231138Fri, 15 May 2015 01:05:08 PDTUK Government Review Says Use Prizes, Not Patents, To Produce Much-Needed New AntibioticsGlyn Moodyhttps://www.techdirt.com/articles/20150514/09341830995/uk-government-review-says-use-prizes-not-patents-to-produce-much-needed-new-antibiotics.shtml
https://www.techdirt.com/articles/20150514/09341830995/uk-government-review-says-use-prizes-not-patents-to-produce-much-needed-new-antibiotics.shtml
A couple of years ago we wrote about how the patent system creates perverse incentives for companies that make antibiotics to exploit them as fully as possible while they are still under patent. That, in its turn, drives antibiotic resistance, which is becoming an extremely serious problem. At the end of our previous post, we noted that this situation would be a perfect opportunity to try something different, such as offering some form of prize to pharmaceutical companies that come up with new antibiotics. Remarkably, the UK government's Review on Antimicrobial Resistance (pdf) has just suggested exactly that:

we want to make antibiotics R&D commercially sustainable so that the field can attract the best minds from research organisations, small biotech companies, large firms or not-for-profit entities. To do that we propose a system by which a global organisation has the authority and resources to commit lump-sum payments to successful drug developers. Payment would have to be set against selective criteria agreed in advance. Such an approach would 'de-link' the profitability of a drug from its volume of sales, supporting conservation goals by eliminating the commercial imperative for a drug company to sell new antibiotics in large quantities -- a key factor in contributing to the development and spread of resistance.

As that notes, the key to this approach is to "de-link" profitability from sales volume so there is no business pressure to over-use new antibiotics. One way to do that is to offer not a patent, but a hefty lump sum to any company that comes up with a new antibiotic. Another benefit is that the scale of the money on offer -- around $2 billion per new antibiotic -- is likely to encourage participation from companies all around the world, especially startups, since the scheme would be open to all. The UK review suggests supporting innovative approaches directly:

A global AMR [antimicrobial resistance] Innovation Fund of around 2 billion USD over 5 years would help boost funding for blue-sky research into drugs and diagnostics, and get more good ideas off the ground. Big pharma should have a role in paying for this innovation fund: it needs to look beyond short-term assessments of profit and loss, and act with ‘enlightened self-interest’ in tackling AMR, recognising that it has a long term commercial imperative to having effective antibiotics, as well as a moral one.

The 44-page document goes into more detail about the thinking behind the proposed scheme, how it might be implemented in practice, and the problems it would face. It's a bold approach, but given the continuing failure of the current patent-based system to come up with new antibiotics, it's one that governments around the world need to consider seriously. After all, as the review warns:

if we fail to act on AMR, then an additional 10 million lives would be lost each year to drug-resistant strains of malaria, HIV, TB, and certain bacterial infections by 2050, at a cost to the world economy of 100 trillion USD.

Compared to that figure, the few tens of billions of dollars needed to implement the new approach has to be a bargain.

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]]>or-it-will-cost-us-$100-trillionhttps://www.techdirt.com/comment_rss.php?sid=20150514/09341830995Thu, 14 May 2015 01:04:42 PDTHere's A Serious Alternative To Big Pharma: CubaGlyn Moodyhttps://www.techdirt.com/articles/20150512/09490530976/heres-serious-alternative-to-big-pharma-cuba.shtml
https://www.techdirt.com/articles/20150512/09490530976/heres-serious-alternative-to-big-pharma-cuba.shtml
Techdirt often points out that the current system of funding the creation of life-saving drugs is broken. But the obvious question is: what can you put in its place? The answer includes things like prizes, but also, it seems, Cuba:

Cuba has for several years had a promising therapeutic vaccine against lung cancer. The 55-year trade embargo led by the US made sure that Cuba was mostly where it stayed.

Leaving aside the fact that politics probably got in the way of saving lives (again), the more interesting issue is how Cuba managed to come up with a lung cancer vaccine. Here's the explanation from the Wired article quoted above:

Though the country is justly famous for cigars, rum, and baseball, it also has some of the best and most inventive biotech and medical research in the world. That's especially notable for a country where the average worker earns $20 a month. Cuba spends a fraction of the money the US does on healthcare per individual; yet the average Cuban has a life expectancy on par with the average American. "They’ve had to do more with less," says [Roswell Park Cancer Institute's CEO] Johnson, "so they’ve had to be even more innovative with how they approach things. For over 40 years, they have had a preeminent immunology community."

The cancer vaccine is not the only important drug Cuba has managed to develop with its limited resources. According to Wired, Cuban scientists have come up with their own vaccines for meningitis B and hepatitis B, and monoclonal antibodies for kidney transplants. That suggests the success of the "do more with less" approach isn't just a one-off, but can be applied consistently to deliver results.

That's important, and not just for people who desperately need new drugs. Big pharma is one of the main industries pushing pseudo-trade agreements like TPP and TTIP. Some of the worst elements in those are driven by that industry's desire to obtain longer patent protection and delay the entry of generics, with the justification that Big Pharma "needs" these extended monopolies to pay for costly research into novel drugs. Alternative approaches like Cuba's, which require far lower investments, offer the hope not just of doing "more with less", but also of calling the pharmaceutical giants' bluff that only they can come up with life-saving new treatments.

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]]>doing-more-with-lesshttps://www.techdirt.com/comment_rss.php?sid=20150512/09490530976Wed, 6 May 2015 01:05:00 PDTStudy: Mismarketing Of Patented Drugs Has Cost Society At Least $380 BillionGlyn Moodyhttps://www.techdirt.com/articles/20150503/02563230867/study-mismarketing-patented-drugs-has-cost-society-least-380-billion.shtml
https://www.techdirt.com/articles/20150503/02563230867/study-mismarketing-patented-drugs-has-cost-society-least-380-billion.shtml
Here on Techdirt we've written many times about the problematic nature of drug patents. They are harmful both directly, in terms of the price distortions they cause and seek to spread to new markets, and indirectly, through the lobbying that the pharma industry deploys to strengthen and extend them, notably in trade agreements such as TPP and TAFTA/TTIP.

The standard justification for these patents is that they are needed to provide incentives for costly research and development of new drugs, something that Techdirt has been questioning for manyyears. A fascinating new paper entitled "Patent Monopolies and the Costs of Mismarketing Drugs" (pdf), by Ravi Katari and Dean Baker at the Center for Economic and Policy Research, explores yet another problem with pharma patents:

in the case of prescription drugs, there are also major costs associated with the enormous asymmetry between the knowledge available to drug companies and the knowledge available to patients and their doctors. As a result of this asymmetry of knowledge, drug companies will often be in a situation to earn large patent rents by concealing information that show their drugs are less effective than they claimed or possibly even harmful.

One way in which drug companies take advantage of this asymmetry is with "off-label" promotion of their drugs. An off-label use of a drug is one which has not been approved by the FDA. While doctors are free to prescribe drugs for off-label uses, drug companies are prohibited from promoting their drugs for off-label uses. If they want to get a drug approved for additional uses then they have to clear a path by seeking FDA approval. However, they routinely avoid this independent assessment by finding ways to promote their drugs for unapproved uses. Promotion of drugs for off-label uses is harmful to the public because it diminishes drug safety regulation, discourages companies from conducting or revealing internal safety studies, and incentivizes them to seek FDA approval for narrow "label use" that is easier to push through the approval process.

The bulk of the paper is concerned with quantifying those costs by looking at five high-profile cases of mismarketing. Here's the final result:

The cumulative costs associated with the increased morbidity and mortality associated with these drugs was $382.4 billion over the 14-year period from 1994–2008. This comes to just over $27 billion a year, an amount that is comparable to what the pharmaceutical industry claims to have been spending on research at the time.

As the paper's authors emphasize, this is only a rough figure, and is likely to underestimate the total negative consequences of this kind of rent-seeking behavior, since it is based on only a small subset of drugs, and uses conservative estimates for key quantities. More important than the specific figure are the policy implications. For example, the deliberate mismarketing is only possible because data is kept secret:

If, for example, this research was all in the public domain and carried through by researchers who had no direct financial interest in the sales of a drug, it is unlikely that they would go to elaborate lengths to misrepresent or conceal research findings, or that they would be successful if they tried. In other words, the costs documented here are the result of the incentives provided by patent monopolies in the same way that the research itself is motivated by patent monopolies.

At the very least, that's an argument for requiring that all research data and clinical trial information should be made freely available for others to analyze. The paper also points out that there are implications for TPP and TAFTA/TTIP:

One of the major goals of the United States in these and other trade pacts currently being negotiated is to strengthen patent and related protections for prescription drugs. The justification is that increased patent rents will provide a greater incentive to the pharmaceutical industry, leading to more innovation.

But as the present study shows, strengthening those protections is likely to encourage more rent-seeking behavior, increased mismarketing, and thus unnecessary deaths and greater costs to society -- hardly something to promote through trade agreements. Finally, the new research adds further weight to the argument that we need to find better ways of funding research into new drugs:

The fact that incentives from patent rents lead firms to promote drugs in ways that impose large costs on patients and society should raise additional questions about the desirability of patent protection as a mechanism for financing research. Other mechanisms for financing research have been proposed, such as a prize system or direct public funding. Of course the U.S. government already spends $30.9 billion annually funding biomedical research through grants administered by the National Institutes of Health, so direct public funding is already an integral part of the drug development process. The proposal is to expand this funding and have NIH’s mission extend to the development and testing of drugs. By having all research in the public domain and taking away the patent rents associated with marketed drugs, direct funding would both remove the incentive and hugely lessen the ability to misrepresent research in order to promote drugs for uses that may not be
appropriate.

When so many lives and so much money are at stake, it's surely time to look at this idea more closely.

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]]>time-for-a-changehttps://www.techdirt.com/comment_rss.php?sid=20150503/02563230867Wed, 7 Jan 2015 08:09:50 PSTThe Nasty Patent Games Drug Companies Play To Stop You From Getting Cheaper DrugsMike Masnickhttps://www.techdirt.com/articles/20141225/06374929525/nasty-patent-games-drug-companies-play-to-stop-you-getting-cheaper-drugs.shtml
https://www.techdirt.com/articles/20141225/06374929525/nasty-patent-games-drug-companies-play-to-stop-you-getting-cheaper-drugs.shtml"Worth" -- which included a few different stories trying to establish how much something is truly "worth." The first story in the collection talked about how much extra time in life is worth, as part of a discussion on whether or not it's reasonable for certain drugs to be priced insanely high. It was an interesting discussion, mostly revolving around the question of whether it's "worth" paying tends of thousands of dollars for a drug treatment that might only extend your life a few weeks. There is just a brief discussion about whether or not it's appropriate for pharmaceutical companies to charge the rates that they do -- with the Radiolab team unfortunately accepting the tired (and incredibly misleading) claim from a drug company that because drug research includes so many failures, it needs to charge these ridiculous high rates to make up for all the failures.

This is misleading in all sorts of ways, though that will need to be the subject of another post at another time. My biggest complaint, after the story was over, was that it failed in economics 101. It stuck with the premise that there was a quantifiable single amount that something was "worth" -- and that price is a reflection of that. This is something that many people tend to feel, instinctively, but it's not accurate. The value of something is different to different people and depends on many factors. The price of something may be quite different than the value -- again, something we've been highlighting for years.

Here's the key bit: the price of something is driven by supply and demand. When you -- as the program did -- look at price solely based on "value" you're only looking at the demand side of the equation, and not the supply. And that's where things get extra tricky in pharmaceutical pricing -- because the supply side is massively distorted through patents, which enable drug companies to artificially limit the supply, driving up prices to insane levels. In a normal, functioning society, we might recognize that this is a problem. Deriving pricing for healthcare solely based on demand is ludicrous, and shows a society with very short-term thinking. It prioritizes short-term narrow profits of drug companies over long-term contributions from a more healthy populace.

But this is the way of our pharmaceutical industry today. And these distortions have become something of, well, a drug to the pharma industry. They've become so fat and happy based on the monopoly rents of patents artificially limiting supply, that they can't fathom how to survive without such rents. That crutch has resulted in big pharma running into some serious problems lately -- because they haven't been discovering many really valuable new drugs lately. At the same time, many of their old drugs have seen their patents start to expire.

In response, pharmaceutical companies have been pulling out all sorts of tricks to try to extend the monopoly rents (rather than actually improving people's health or their own business model). For a while, we were discussing "pay for delay" schemes, in which big pharmaceutical companies would sue small generic drug makers... and then "settle" by paying those generic companies a bunch of cash not to compete with generic drugs for some time. That practice recently became harder after the Supreme Court said that the FTC can go after such practices as a form of antitrust enforcement.

But that's not the only game that big pharmaceutical firms have been playing. A recent lawsuit filed by New York against Forest Labs and its parent company Actavis revealed that the company was trying to force Alzheimer's patients onto a new drug, and away from one that they had been using. The only real difference in the two drugs: the length of the patent protection. Basically, the company was trying to force patients onto a drug that wasn't close to becoming available in generic forms, which would make it much, much cheaper. From the lawsuit:

This case is brought to prevent Defendants from illegally maintaining their
monopoly position and inflating their profits at the expense of patients suffering from
Alzheimer's disease. The manipulative tactic that the Defendants seek to employ here is what
some in the industry, including Defendants' own CEO, have called a "forced Switch." In a
forced switch, a pharmaceutical company that sells a drug facing imminent generic competition
withdraws its drug from the market, forcing patients to switch to a different form of the drug
with patents that expire later. The switch has the effect of impeding the entry of lower-cost
generic drugs. A physician recently complained to Defendants, aptly describing their
contemplated action as "immoral and unethical." It is also illegal.

Defendants sell a blockbuster drug to treat Alzheimer's disease, called Namenda.
Namenda is Forest's top selling drug, and is protected by patent and regulatory exclusivities that
prevent generic versions from entering the market until July 2015. But rather than allowing
patients with Alzheimer's to continue to take Namenda and switch to the less expensive generic
version when it becomes available, as contemplated by federal and state drug laws, Forest
instead hatched a scheme that interferes with patients' ability to make this switch.

Defendants' strategy is to discontinue or severely restrict patient access to its
original, immediate-release version of Namenda, known as Namenda IR, prior to generic entry in
order to force patients to switch to Forest's newer, virtually identical, extended-release version of
Namenda, called Namenda XR. Because Namenda XR is protected by patents for many years
longer than the original Namenda IR, Defendants' goal is to use the "forced switch" to reap
several more years of monopoly profits than they would have earned otherwise. Under generic
substitution laws, a pharmacist will not be able to substitute lower-priced generic Namenda IR
(known as memantine) for Namenda XR. As a result, once patients have switched to
Namenda XR, it will destroy the market for the generic form of Namenda IR because of the
dramatically increased burden, cost, and time needed to arrange for patients who have been
switched to Namenda XR to switch back to the original version.

Thankfully, a few weeks ago, an initial ruling in the case found that Actavis could not move forward with these "forced switch" plans and needed to continue making the original drug, Namenda IR, available. The full court ruling [pdf] is fairly detailed in how Actavis has a monopoly on the market for memantine and is abusing it in anti-competitive ways. The court notes that merely having a patent isn't necessarily proof of a monopoly -- but in this case, Actavis absolutely does have a monopoly. Further, it notes that just because you have a monopoly, it doesn't mean you're abusing it. But... Actavis does appear to be abusing its monopoly position. It didn't help that Forest Labs CEO, Brent Saunders (recently moved up to Actavis CEO as well), was pretty open about this:

Saunders stated, contemporaneously with the adoption
of the hard switch by Forest, that the purpose of the switch was
anticompetitive: to put barriers obstacles in the path of
producers of generic memantine and thereby protect Namenda’s
revenues from a precipitous decline following generic entry.... He further stated: “if we do the hard switch and
we’ve converted patients and caregivers to once-a-day therapy
versus twice a day, it’s very difficult for the generics then to
reverse-commute back, at least with the existing
[prescriptions]. They don’t have the sales force, they don’t
have the capabilities to go do that. It doesn’t mean that it can’t happen, it just becomes very difficult. It is an obstacle
that will allow us to, I think, again go into to a slow decline
versus a complete cliff.”).

Of course, this particular practice, of trying to force people to avoid generic competition is increasingly widespread. As I was finishing up this post, I came across a similar, if equally disturbing, story about Pfizer directly threatening doctors should they decide to prescribe generic versions of pregabalin, an anti-epilepsy drug, that will also go off patent in 2015. But here's the tricky part: Pfizer holds a different patent on the same drug if it's used to treat pain (rather than epilepsy). Pfizer is claiming that prescribing the generic version for pain use would lead to serious problems -- even though it's the same damn drug.

You will see that, whilst the basic patent for pregabalin has expired and regulatory data protection for Lyrica expired in July 2014, Pfizer has a second medical use patent protecting pregabalin's use in pain which extends to July 2017. Pfizer conducted further research and development on pregabalin leading to the invention of its use in pain and hence was granted a second medical use patent for this indication. This patent does not extend to pregabalin's other indications for generalized anxiety disorder (GAD) or epilepsy.

As a result of the pain patent, we expect that generic manufacturers will only seek authorisation of their pregabalin products for use in epilepsy and generalised anxiety disorder and not for pain, whilst Pfizer's pain patent is in place. Generic pregabalin products therefore are expected not to have the relevant information regarding the use of the product in pain in the PIL (Patient Information Leaflet) and SmPC (Summary of Product Characteristics). In other words, the generic pregabalin products are expected to carry so-called "skinny labels" and will not be licensed for use in pain. In the circumstances described above, Pfizer believes the supply of generic pregabalin for use in the treatment of pain whilst the pain patent remains in force in the UK would infringe Pfizer's patent rights. This would not be the case with supply or dispensing of generic pregabalin for the non-pain indications, but we believe it is incumbent on those involved to ensure that skinny labeled generic products are not dispensed and used for pain.

In this regard, we believe the patent may be infringed, even potentially unwittingly, by pharmacists and others in the supply chain, if they supply generic pregabalin for the pain indication. Without information, guidance and practical solutions from the authorities, Pfizer believes that multiple stakeholders, possibly without realizing, may contribute to patent infringement which would be an unlawful act. This runs contrary to the government's established policy of rewarding additional research by the granting of a second medical use patent.

As Cory Doctorow notes in the article above, Pfizer here seems to be trying to take its own "stupid problem" and make it everyone else's stupid problem:

Weirder still is that Pfizer wants to make their stupid problem into everyone else's stupid problem. The fact that it's hard to enforce this kind of secondary patent is Pfizer's business, not doctors'. Doctors' duty is to science and health, not Pfizer's profit-margins. Scientifically, there's no difference between the two compounds. Doctors who prescribe generics leave their patients (or possibly the NHS) with more money to pursue their other health goals.

If your dumb government monopoly is hard to enforce, maybe you shouldn't be banking on it. But in the world of corporatist sociopathy, where externalising your costs on others isn't just a good idea, it's your fiduciary duty to your shareholders, Pfizer's actions are practically inevitable.

And this brings us back to the problem discussed at the very top of this article. The entire pharmaceutical industry has built its business around the idea of artificially reducing supply -- rather than about providing more benefit (health). That's really screwed up. A good business focuses on expanding the benefit to users, not limiting it to charge more. Our patent policy has created incentives for exactly the opposite -- and that is having a massive impact on the health and well-being of people around the globe.

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]]>the-evilness-of-drug-companieshttps://www.techdirt.com/comment_rss.php?sid=20141225/06374929525Wed, 5 Nov 2014 12:45:00 PSTPharma Officials Insist That There Is 'Zero Evidence' That Patents Harm Access To MedicineMike Masnickhttps://www.techdirt.com/articles/20141104/17103829041/merck-exec-top-pharma-lobbyist-insists-that-there-is-zero-evidence-that-patents-harm-access-to-medicine.shtml
https://www.techdirt.com/articles/20141104/17103829041/merck-exec-top-pharma-lobbyist-insists-that-there-is-zero-evidence-that-patents-harm-access-to-medicine.shtmljust elected as the new head of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) -- basically, the big pro-pharma lobbying group. The tweet is no longer there, because LillyPad deleted it, but here's a screenshot I took apparently seconds before it disappeared:

As you can see, they're quoting Oschmann insisting that "there is zero evidence that intellectual property is a hindrance to access to medicines." Almost immediately, you can see that nearly all of the responses started pointing to... um... evidence of how patents are a hindrance to access to medicine. Here's an OxFam paper and a massive paper from Medicins San Frontieres (MSF) Access Campaign, which focuses specifically on improving access to life-saving medicines. Lots of other comments were just mocking the claim, with some asking if Lilly was going to post a correction.

Perhaps recognizing just how ridiculous the whole thing looked, Lilly went with option "pretend it never happened" and deleted the tweet. What might have been better and more productive would have been to come out and admit that the statement was bullshit and that there are legitimate concerns about how patents can hold back access to medicine. An intellectually honest organization might then try to kick off a discussion about the different issues and the tradeoffs, recognizing that patents clearly do harm access, but potentially could also create incentives that lead to new drug creation (this is the standard claim, anyway, though some are skeptical of that as well).

But it appears that Eli Lilly (and IFPMA) have no interest in being intellectually honest or having such a discussion. No, they've decided to stick to the ridiculous and bogus corporate line that patents are all butterflies and roses, and do no harm at all. What a wasted opportunity -- even if it helped show the true colors of the current leadership of the pharmaceutical industry.

And it's even more ridiculous that this all took place at an IFPMA event where "global health" was the key topic, and they talked about "inclusiveness" and "sustainability" along with transparency. But, in the end that's all clearly buzzwords and smoke screens, because when its new boss makes a stupid, clearly incorrect statement that shows what the industry is all about, the message gets hidden and there's no discussion or transparency at all. For shame.

As for Dr. Oschmann, seeing as he's a long-term Merck exec, he'd do well to remember the words of George Merck, from nearly a century ago:

We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been.

It appears that sentiment has long since been beaten out of Merck.

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]]>just-because-you-don't-look,-doesn't-mean-it's-not-therehttps://www.techdirt.com/comment_rss.php?sid=20141104/17103829041Wed, 29 Oct 2014 11:38:00 PDTFDA Is Angry That ICANN Won't Just Censor Websites On Its Say SoMike Masnickhttps://www.techdirt.com/articles/20141029/07223828977/fda-is-angry-that-icann-wont-just-censor-websites-its-say-so.shtml
https://www.techdirt.com/articles/20141029/07223828977/fda-is-angry-that-icann-wont-just-censor-websites-its-say-so.shtmlCity of London Police demanding that websites be taken offline without any due process. It appears that the US Food & Drug Administration (FDA) is getting in on the game as well. The Wall Street Journal recently published a detailed article about how angry the FDA is with ICANN (there's also a corresponding blog post which may not face the same paywall restrictions) for not simply killing domains that the FDA deems "rogue pharmacies." That's not to say that there aren't reasonable concerns about rogue pharmacies. There are clearly some concerns about those sites, but it seems like there are better ways to deal with those than just barging in and saying that ICANN and registrars need to take down sites based solely on their say so.

In July, the FDA teamed with Interpol and dozens of countries to try to shut down more than 1,300 websites suspected of selling drugs without a prescription. Officials sent a list of all the websites, carrying names such as buyoxycontinonline.com and approvedonlinepharmacy.net, to the Chinese company that registered them. The company replied with a request for a court order and then sent a terse follow-up email: “It is not possible for us to take action.”

In frustration, officials turned to the Internet’s central administrator, an organization called the Internet Corp. for Assigned Names and Numbers, or Icann. Its contract with the registrar, BizCN.com, requires the company to investigate reports of illegal behavior.

But here's the thing. Everyone in the articles (including the reporters) seem to take it as perfectly reasonable that ICANN and/or these registrars should have just taken down these sites. No one points out that BizCN seemed to respond properly by asking for a court order. ICANN isn't in the business of censorship. It shouldn't be the one to determine if a site is an illegal pharmacy or not. There's a reason why we have due process and courts to adjudicate decisions like that. Putting the entire burden on registrars and/or ICANN to act as internet cops, ready to take down sites at a notification's notice seems tremendously problematic.

It's a recipe for censorship, stifling free speech and hindering innovation. And yet, that's what the FDA and others want:

Because of its central role, regulators and law-enforcement agencies around the world say Icann could be crucial to their crackdown on illicit Internet operators of all kinds.

Already, just in the online pharmacy space, we've seen how certain pharmaceutical companies like to conflate the small number of truly "rogue" pharmacies that sell either counterfeit drugs or real drugs without proper procedures, with perfectly safe and legal Canadian pharmacies that many Americans rely on for cheaper drugs. The big pharmaceutical companies would like to shut down that competition, even as American politicians have explored expanding the ability of US citizens to get their drugs from such pharmacies. And that's why it's reasonable to ask for an actual court order before taking down sites -- rather than just assuming that some bureaucrat at the FDA can accurately determine which sites are "good" and which are "bad," and then demand that registrars or ICANN automatically take action.